Cleared Traditional

K221857 - Aneroid sphygmomanometer with stethoscope

K221857 is an FDA 510(k) clearance for Aneroid sphygmomanometer with stethoscope, manufactured by Zhejiang Lude Technology Development Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K221857 · Zhejiang Lude Technology Development Co., Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2022
Decision
108d
Days
Class 2
Risk

K221857 is an FDA 510(k) clearance for the Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, Q.... Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Zhejiang Lude Technology Development Co., Ltd. (Wenzhou, CN). The FDA issued a Cleared decision on October 13, 2022 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Zhejiang Lude Technology Development Co., Ltd. devices

FDA 510(k) Submission Details - K221857

510(k) Number K221857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2022
Decision Date October 13, 2022
Days to Decision 108 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 125d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXQ Device Classification - Class 2, Special Controls

Product Code DXQ Blood Pressure Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1120
Definition A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXQ Blood Pressure Cuff

All 87
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K221857.
ONE-CUF
K230145 · Ge Medical Systems Information Technologies, Inc. · Mar 2023
Aneroid Sphygmomanometer
K222652 · Cardicare Company, Ltd. · Nov 2022
Disposable Blood Pressure Cuff
K222420 · Wenzhou Xikang Medical Instruments Co., Ltd. · Nov 2022
WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203
K212416 · Wenzhou Xikang Medical Instruments Co., Ltd. · May 2022
Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope
K211084 · Shanghai Caremate Medical Device Co., Ltd. · Oct 2021
Reusable NIBP Cuff
K211747 · Shenzhen Coreray Technology Co., Ltd. · Sep 2021